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OpenTrials
Completed

NCT Number: NCT02644694

PK Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients Undergoing Vitrectomy

The purpose of this study is to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

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Key information

Conditions

Vitrectomy

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

About this study

This is an open-label, multi-center, single-dose, Phase 1 clinical trial designed to evaluate the pharmacokinetics (PK) of dexamethasone phosphate ophthalmic solution delivered via the EyeGate® II Drug Delivery System (EGDS) in the vitreous humor taken from patients undergoing vitrectomy for macular hole repair or epiretinal membrane peeling

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 to 85 years
  • Receive, understand, and sign a copy of the written informed consent form

Exclusion criteria

-

Treatment and study plan

Dexamethasone Phosphate Ophthalmic Solution

Drug

Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System

Primary outcomes

  1. Concentration of dexamethasone

    Time frame: Day 1

    Vitreous humor samples will be analyzed for dexamethasone concentrations

  2. Concentration of dexamethasone phosphate

    Time frame: Day 1

    Vitreous humor samples will be analyzed for dexamethasone phosphate concentrations

Sponsors and collaborators

Lead sponsor

Eyegate Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Prospective, Multi-Center, Single-Dose, Phase 1 Clinical Trial Designed to Evaluate the Pharmacokinetics of Dexamethasone Phosphate Ophthalmic Solution Delivered Via the EyeGate® II Drug Delivery System in Patients Undergoing Vitrectomy for Macular Hole Repair or Epiretinal Membrane Peeling

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 1, 2016
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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